Cleared Traditional

DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS

K040120 · DiaSorin, Inc. · Microbiology
Apr 2005
Decision
465d
Days
Class 1
Risk

About This 510(k) Submission

K040120 is an FDA 510(k) clearance for the DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS, a Test, Antigen, Nuclear, Epstein-barr Virus (Class I — General Controls, product code LLM), submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on April 29, 2005, 465 days after receiving the submission on January 20, 2004. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number K040120 FDA.gov
FDA Decision Cleared SESE
Date Received January 20, 2004
Decision Date April 29, 2005
Days to Decision 465 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LLM — Test, Antigen, Nuclear, Epstein-barr Virus
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3235

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